99 results
·
13ms
·
Sources: EU EUDAMED, US FDA
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016
AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.
FDA Recall
Terminated
·Micromedical Technologies, Inc·Product code ETP·November 16, 2009
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
FDA Recall
Terminated
·Exact Sciences Corporation·Product code PHP·April 28, 2017
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
FDA Recall
Terminated
·Epigenomics Ag Geneststr. 5 Berlin Germany·Product code PHP·November 2, 2017
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code ETP·December 21, 2011
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
FDA Recall
Terminated
·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018
Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009
Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009
Ellex Super Q LQP3106 ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
FDA Recall
Terminated
·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020
Alcon 3000LE ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Recall
Terminated
·Care Essentials Pty., Ltd.·Product code DWJ·January 7, 2020
Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Ultra Q LQP3106-U ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019